What is the percentage of adverse events after the AMULET (Amulet, a type of Left Atrial Appendage Closure device) procedure?

From the Guidelines

The percentage of adverse events after the Amulet procedure is approximately 2-5%, with major adverse events occurring in about 3-5% of cases.

Adverse Events Overview

The Amulet procedure, a left atrial appendage occlusion device, has been studied in various clinical trials to assess its safety and efficacy. According to the most recent and highest quality study, the PRAGUE-17 trial 1, the Amulet device was non-inferior to the Watchman device for safety events, including procedure-related thromboembolism, death, or major bleeding.

Major Adverse Events

Major adverse events associated with the Amulet procedure include:

• Pericardial effusion/tamponade (1-2%)
• Device embolization (0.5-1%)
• Stroke (0.5-1%)
• Major bleeding (1-2%) Procedure-related death is rare, occurring in less than 0.5% of cases.

Minor Complications

Minor complications, such as access site hematomas, minor bleeding, and transient arrhythmias, occur in approximately 5-8% of patients. Device-related thrombus formation is reported in 1-3% of cases during follow-up.

Comparison to Other Devices

The Amulet device generally shows comparable or slightly lower adverse event rates compared to other left atrial appendage closure devices, such as the Watchman device 1.

Clinical Implications

Most serious complications occur within the first 7 days post-procedure, with the risk decreasing substantially thereafter. The Amulet procedure may be considered in patients with atrial fibrillation and contraindications for long-term anticoagulant treatment to prevent ischemic stroke and thromboembolism, as recommended by the 2024 ESC guidelines 1.

From the Research

Adverse Events after Amulet Procedure

• The percentage of adverse events after the Amulet procedure varies across studies:
  • A study published in EuroIntervention in 2017 reported major adverse events in 3.2% of patients during the procedure and index hospitalisation 2.
  • Another study published in the Cardiology journal in 2017 found major periprocedural adverse events in 8% of patients, including device embolization, pericardial effusions, and prolonged hospital stay due to retropharyngeal hematoma 3.
  • A study published in Catheterization and cardiovascular interventions in 2019 reported a trend toward more periprocedural major adverse events in patients with incomplete LAA ostium coverage due to disc prolapse, with a rate of 7.1% in this group 4.
  • The SWISS-APERO randomized clinical trial published in Circulation in 2022 found that major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%) due to more frequent bleeding 5.
  • A prospective global observational study published in the European heart journal in 2020 reported major adverse events in 4.0% of patients, including death, stroke, major vascular complications, and device embolization 6.

Types of Adverse Events

• The types of adverse events reported after the Amulet procedure include:
  • Device embolization
  • Pericardial effusions
  • Prolonged hospital stay due to retropharyngeal hematoma
  • Bleeding complications
  • Stroke
  • Cardiovascular death
  • Device-related thrombus

Rates of Adverse Events

• The rates of adverse events after the Amulet procedure are as follows:
  • Major adverse events: 3.2% to 9.0% 2, 5
  • Device embolization: 0.2% to 2% 2, 3
  • Pericardial effusions: 1.3% to 2% 2, 3
  • Bleeding complications: 1.8% to 7.2% 5
  • Stroke: 0.4% to 2.2%/year 2, 6
  • Cardiovascular death: 0.3% to 8.7% at 2 years 2, 6
  • Device-related thrombus: 1.5% to 1.6% 2, 6